Efficient, High-Titer Monoclonal Antibody Production In A Fed-Batch Process

This application note shows the feasibility of monoclonal antibody (MAb) production in fed-batch processes using the single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems. Cell expansion was performed in a 15 L rocking bioreactor culture to seed a 200 L stirred-tank bioreactor culture. To compare the performance of ReadyToProcess WAVE 25 with that of XDR-200, 7 L of the 200 L culture was transferred to a parallel ReadyToProcess WAVE 25 system to a total culture volume of 10 L. MAb yields from the parallel productions were 5.0 and 4.9 g/L for XDR-200 and ReadyToProcess WAVE 25, respectively. The metabolite profiles were very similar in both bioreactor cultures. Together, the ReadyToProcess WAVE 25 and Xcellerex XDR bioreactor systems provide a powerful solution for robust, scalable production of recombinant proteins in a singleuse format. In addition, the ReadyToProcess WAVE 25 is a versatile tool that can be used for both seed-train applications and process development.